Optimize RV Selective Site Pacing Clinical Trial

January 24, 2013 updated by: Medtronic Cardiac Rhythm and Heart Failure
The purpose of the Optimize RV study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of select site pacing is to improve how the heart contracts when paced in the ventricle. By pacing in select sites, it is possible to better copy the natural pattern of contraction of the heart.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal, Canada
  • China
      • Hong Kong, China
  • Israel
      • Ramat Gan, Israel
  • Italy
      • Firenze, Italy
      • Rovigo, Italy
  • Qatar
      • Doha, Qatar
  • United States
    • Connecticut
      • Bridgeport, Connecticut, United States
    • Florida
      • Clearwater, Florida, United States
      • Hudson, Florida, United States
    • Iowa
      • Des Moines, Iowa, United States
    • Maryland
      • Silver Spring, Maryland, United States
      • Takoma Park, Maryland, United States
    • Michigan
      • Southfield, Michigan, United States
    • Minnesota
      • Saint Paul, Minnesota, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Tomball, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Vermont
      • Burlington, Vermont, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects that are expected to be paced in the right ventricle (RV) greater than 90 percent of the time
  • Subjects with an ejection fraction of greater than 40 percent within 3 months prior to enrollment
  • Subjects greater than 18 yrs of age
  • Subjects that are indicated for a dual chamber pacemaker
  • Subjects that will be implanted with a market released dual chamber Medtronic pacemaker and 3830 SelectSecure Lead in the ventricle

Exclusion Criteria:

  • Subjects indicated for cardiac resynchronization therapy (CRT) device (based on American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines)
  • Subjects indicated for an implantable cardiac defibrillator (ICD)
  • Subjects with permanent atrial fibrillation (AF)
  • Subjects with expected managed ventricular pacing turned on
  • Subjects with a previously implanted pacemaker, ICD, or CRT device
  • Subjects with an myocardial infarction (MI) within 3 months prior to enrollment
  • Subjects that received bypass surgery within 3 months prior to enrollment
  • Subjects that had valve replacement within 3 months prior to enrollment
  • Subjects where a RV lead cannot be placed, (i.e., complex congenital heart disease
  • Subjects with a mechanical right heart valve
  • Women who are pregnant or nursing
  • Significant co-morbidity preventing study completion
  • Terminal conditions with a life expectancy of less than two years
  • Participation in another study that would confound the results of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: RV Mid-Septal Pacing
Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
Device: Medtronic Dual-Chamber Pacemaker
A Medtronic market-approved dual-chamber implantable pulse generator (IPG)
Device: Medtronic SelectSecure 3830 Lead
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead
ACTIVE_COMPARATOR: RV Apical Pacing
Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
Device: Medtronic Dual-Chamber Pacemaker
A Medtronic market-approved dual-chamber implantable pulse generator (IPG)
Device: Medtronic SelectSecure 3830 Lead
Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in Left Ventricular (LV) Ejection Fraction From Baseline to Two Year Follow-up
Time Frame: Baseline and 24 months
Left ventricular ejection fraction (LVEF) will be measured at baseline and two year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from baseline to two year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.
Baseline and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in LVEF From Two Week Visit to Two Year Follow-up
Time Frame: Baseline and 24 months
Left ventricular ejection fraction (LVEF) will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LVEF from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LVEF.
Baseline and 24 months
The Change in Six-minute Hall Walk Distance
Time Frame: Baseline and 24 months
The change in six-minute hall walk distance will be measured at two week visit and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in six-minute hall walk distance will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in six-minute hall walk distance.
Baseline and 24 months
The Change in Left Ventricular (LV) End Systolic Volume (Diastolic Volume) After Two Years Follow-up
Time Frame: Baseline and 24 months
LV end systolic volume (diastolic volume)will be measured at baseline and 2 year follow-up for the group of pacing at RV Mid-Septum and the group of pacing at Apex. The change in LV end systolic volume (diastolic volume)from two week visit to 2 year follow-up will be compared between two groups to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on the change in LV end systolic volume (diastolic volume).
Baseline and 24 months
Clinical Event (AT/AF Pnly or Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to Two Year Follow-up
Time Frame: Baseline and 24 months
Clinical event (AT/AF pnly or composite of worsening of heart failure, stroke or death) rate from baseline to two year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event rate.
Baseline and 24 months
Clinical Event (Composite of Worsening of Heart Failure, Stroke or Death) Rate From Baseline to 2 Year Follow-up
Time Frame: Baseline and 24 months
Clinical event (composite of worsening of heart failure, stroke or death) rate from baseline to 2 year follow-up will be estimated and compared between the group of pacing at RV Mid-Septum and the group of pacing at Apex to identify if pacing at selective RV sites (Mid-Septum or Apex) will have a different long term impact on clinical event(composite of worsening of heart failure, stroke or death)rate.
Baseline and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Chair: Optimize RV Team, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

January 12, 2007

First Submitted That Met QC Criteria

January 12, 2007

First Posted (ESTIMATE)

January 17, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 24, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 604

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Pacemaker, Artificial

Clinical Trials on Medtronic Dual-Chamber Pacemaker

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe